A Study of ZL-1310 in Participants With Selected Solid Tumors

Launched by ZAI LAB (SHANGHAI) CO., LTD. · Mar 19, 2025

Keywords

ClinConnect Summary

This is an open-label, multiple-center, phase Ib/II study of ZL-1310 in selected solid tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent
• • Adult men and women ≥18 years of age
• • Participants must have histologically confirmed, locally advanced or metastatic NECs, and must have experienced disease progression on or after platinum-based therapy
• • Participants must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample
• • Participants must have at least one measurable target lesion as defined by RECIST v1.1
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• • Life expectancy ≥ 3 months
• Exclusion Criteria:
• • Participants with another known malignancy that is progressing or requires active treatment within the last 2 years
• • Clinically active central nervous system (CNS) metastases
• • Participants with leptomeningeal metastasis
• • Participants who have received any ADC with a payload of topoisomerase I inhibitor (e.g., exatecan derivative)
• • Treatment with any systemic anti-cancer treatment or other investigational products/device within 3 weeks before the first dose of study treatment
• • Non-palliative radiotherapy within 2 weeks prior to first dose of study treatment or a history of radiation pneumonitis
• • Major surgery within 4 weeks of the first dose of study treatment
• • Hypersensitivity to any ingredient of the study treatment
• • Out of range value (as defined in protocol) within 10 days prior to the first dose of study treatment
• • Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
• • Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders including but not limited to pneumonitis
• • Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
• • Pregnant or nursing (lactating) women
• • Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer